| CTRI Number |
CTRI/2022/07/044390 [Registered on: 27/07/2022] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO STUDY THE EFFECT OF CITRULLUS COLOCYNTHIS IN KIDNEY DISEASE CAUSED BY DIABETES |
|
Scientific Title of Study
|
TO STUDY THE EFFECT OF CITRULLUS COLOCYNTHIS IN PATIENTS WITH DIABETIC NEPHROPATHY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R S Yadav |
| Designation |
Professor & Head |
| Affiliation |
Dr Rajendra Prasad Govt Medical College Kangra at Tanda |
| Address |
Department of Biochemistry
Dr Rajendra Prasad Govt Medical College Kangra at Tanda
Department of Biochemistry
Dr Rajendra Prasad Govt Medical College Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
|
| Email |
rsy1962@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R S Yadav |
| Designation |
Professor & Head |
| Affiliation |
Dr Rajendra Prasad Govt Medical College Kangra at Tanda |
| Address |
Department of Biochemistry
Dr Rajendra Prasad Govt Medical College Kangra at Tanda
Department of Biochemistry
Dr Rajendra Prasad Govt Medical College Kangra at Tanda
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
|
| Email |
rsy1962@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renu |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Govt Medical College Kangra at Tanda |
| Address |
Department of Biochemistry
Dr Rajendra Prasad Govt Medical College Kangra at Tanda
Department of Biochemistry
Dr Rajendra Prasad Govt Medical College Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816717104 |
| Fax |
|
| Email |
reinudhadwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Govt Medical College |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Govt Medical College Kangra at Tanda |
| Address |
Dr Rajendra Prasad Govt Medical College Kangra at Tanda HP pin code 176001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Renu |
Kangra at Tanda HP 176001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Renu |
Dr.Rajendra Prasad Govt Medical College |
Department of Biochemistry
Kangra
HIMACHAL PRADESH |
9816717104
reinudhadwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Dr. Rajendra Prasad Government Medical College (Dr. RPGMC) Kangra at Tanda, Himachal Pradesh, India – 176 001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
citrullus colocynthis |
aqueous extract of citrullus colocynthis a dose of 1-2ml per day orally for 8 weeks. and all other hypoglycemic drugs prescribed by physician. |
| Comparator Agent |
Placebo |
placebo in which all other hypoglycemic drugs as prescribed by physician along with dose mashed placebo agent will be given for 8weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients those who are suffering from diabetic nephropathy |
|
| ExclusionCriteria |
| Details |
i) Subject’s refusal.
ii) Subjects with chronic illness like tuberculosis, cancer or immuno-compromised states.
iii) Pregnant or lactating mothers.
iv) Anyone who has either donated or received blood in last 2 weeks.
v) Use of any drugs affecting electrolytes at the time of data collection.
vi) Anyone on nutritional supplements, such as magnesium containing laxatives.
vii) Chronic disorders of the liver, kidney and cardiovascular system.
viii) Endocrine disorders
ix) Established psychiatric disorder and on antidepressant and /or antipsychotic therapy
x) HIV/AIDS, malignancy and substance abuse.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To improve glycemic control in diabetic nephropathy |
0 weeks ,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce proteinuria in diabetic nephropathy |
0 weeks, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
PRINT ISSN No. 2277 - 8179 | DOI : 10.36106/ijsr |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Anti Diabetic properties of citrullus colocynthis has been well documented so our study aims to study its effect in patients with Diabetic Nephropathy. |